ES2961319T3 - Bone marrow access device and system that includes it - Google Patents

Abstract

The bone marrow access apparatus (10) includes a bone penetration member (12) having an internal channel (30) having openings at the proximal and distal ends, and a valve cap (14) coupled therewith. . The valve cover (14) defines an interior cavity in which at least part of the bone penetrating member (12) is located. The valve cover (14) includes a valve (52) having an opening that has an open state in which the channel (30) is not obstructed and a closed state that prevents the flow of material through the channel (30). . By being repeatedly switchable between open and closed states, the valve (52) controls access to the channel (30) by bone marrow sampling and biopsy instruments. The bone marrow access system includes the bone marrow access apparatus (10) and an installation instrument including a flange and a drill bit. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Bone marrow access device and system that includes it

field of invention

The present invention relates generally to a bone marrow access apparatus that can provide easy and repeatable access to a patient's bone marrow, to tools for installing and removing the bone marrow access apparatus, and to instruments for its use. with the bone marrow access device when installed. The present invention also relates generally to a bone marrow access system including the bone marrow access apparatus.

Background of the invention

The bone marrow is the main site of blood cell formation and, while at birth it is located within almost all bones, by adolescence it is located primarily within the axial bones (for example, the pelvis and femur). Bone marrow exists in the inner portion of the bones, referred to herein as the marrow space, and contains the precursor stem cells that eventually become red blood cells, white blood cells, and platelets.

Bone marrow aspirations and biopsies are common tests used to evaluate bone marrow for leukemias and other hematologic disorders, for example. A marrow sampling from the marrow space can determine cell number, cell shape, and cell maturation. Special pathological stains and molecular studies in marrow samples can establish certain diagnoses. Marrow sampling from the marrow space can be performed at multiple times during a patient's treatment program to evaluate progress. WO 2016/057090 describes a bone marrow apparatus comprising a bone penetrating member having an internal channel, a valve cap comprising a valve that can repeatedly switch between open and closed states. US-5-332-398 relates to the provision of an intramedullary catheter to allow repetitive delivery or withdrawal of fluids to or from the bone marrow vascular system through a catheter device.

Conventionally, to access a patient's bone marrow, the bone must be drilled each time a doctor needs to access the marrow. This is painful for the patient and places a significant burden on the physician and healthcare resources.

There is a need for an implantable bone marrow access device that can be retained subcutaneously in a patient's bone throughout the course of treatment to allow repeated access to the bone marrow without requiring repeated bone punctures.

Summary of the invention

According to a first aspect of the invention, as claimed in claim 1, there is provided a bone marrow access apparatus (10) comprising: a bone penetrating member (12) having an internal channel (30) having a opening (32) at a proximal end (34) and an opening (36) at a distal end (38); and a valve cover (14) coupled with the bone penetration member (12), the valve cover (14) defining an interior cavity (44) in which at least part of the bone penetration member (12) is located, wherein the valve cover (12) comprises a valve (52) having an opening (54) that has an open state where the channel (30) is not obstructed and a closed state that prevents the flow of material through said channel, wherein the valve (52) can be repeatedly switched between open and closed states, wherein the valve cover (14) comprises a peripheral wall (46), a top wall (48) provided above the member ( 12) of bone penetration and extending inwardly from a region of the upper edge of the peripheral wall (46), and a lower edge (50) extending inwardly from a lower edge region of the peripheral wall (46) , and the valve (52) is provided on the upper wall (48), where the bone penetration member (12) has a top surface and a seat (40) that is below the top surface, and the seat can be engage with an installation or extraction instrument (70, 86) to install or remove the bone penetration member (12) in the bone (8), and where the seat (40) forms part of the internal channel. Other embodiments of the invention are defined by the dependent claims. No surgical methods are claimed.

In some embodiments, the bone penetrating member (12) comprises an axially extending insertion portion (16) and a head portion (24) having a larger cross-sectional area than the insertion portion (16); and the channel (30) extends through the insertion portion (16) and the head portion (24) between the openings (32, 36) at the proximal and distal ends (34, 38);

In some embodiments, the bone penetrating member (12) comprises: a thread (18) on an outer surface thereof; and grooved edges (22) at a distal end thereof; wherein the fluted edges are provided in a plurality of positions around the opening (36) at the distal end (38) of the channel (30).

In some embodiments, the seat (40) has a polygonal shape.

In a further aspect, a bone marrow access system is provided, comprising: the bone marrow access apparatus (10) according to the first aspect; and an installation instrument (70) comprising: a flange (76); and a drill bit (78) extending beyond the flange (76), wherein the flange (76) is shaped to fit into the seat (40) of the bone marrow access apparatus (10).

In some embodiments according to the second aspect, the bone penetrating member (12) comprises an axially extending insertion portion (16) and a head portion (24) having a cross-sectional area greater than the insertion portion ( 16); and the channel (30) extends through the insertion portion (16) and the head portion (24) between the openings (32, 36) at the proximal and distal ends (34, 38);

In some embodiments according to the second aspect, the bone penetration member (12) comprises: a thread (18) on an outer surface thereof; and grooved edges (22) at a distal end thereof; wherein the fluted edges are provided in a plurality of positions around the opening (36) at the distal end (38) of the channel (30).

In some embodiments according to the second aspect, the seat (40) has a polygonal shape, and the flange (76) has a corresponding polygonal shape. In some embodiments, the seat (40) is positioned to be accessible by the installation instrument (70) by inserting the installation instrument (70) through the valve (52).

In some embodiments according to the second aspect, the installation instrument (70) further comprises a handle (72) and an elongated shaft (74) attached at one end to the handle (72) and at the other end to the flange (76), and the drill bit (78) is attached to the flange (76).

In some embodiments according to the second aspect, the drill bit (78) has a length greater than the length of the channel (30) under the seat (40), so that when the flange (76) is located in the seat (40), The drill bit (78) extends below a lower surface (20) of the bone penetrating member (12).

In some embodiments according to the second aspect, the bone marrow access system further comprises: at least one sampling needle (66, 80) that can be inserted through the valve (52); and/or a removal tool (86), wherein the removal tool comprises: a flange (92) at one end shaped to fit into the seat (40); a handle (88); and an elongated shaft (90) attached at an end region to the handle (88), the flange (92) attached to the shaft (90) at an end region opposite the shaft of the handle (88).

Summary

An objective of one or more embodiments of the present invention is to provide an improved bone marrow access apparatus that allows repeated sampling of bone marrow at multiple time points without the need for repeated bone punctures through the bone cortex (the portion outside of the bone that has nerves that make punctures painful). The subcutaneous location of the device, compared with an externalized device, is also likely to reduce infection from repeated sampling.

A bone marrow access apparatus according to the disclosure includes a bone penetrating member having an internal channel having an opening at a proximal end and an opening at a distal end, and a valve cap coupled with the bone penetrating member. . The valve cap defines an interior cavity in which part of the bone penetrating member is disposed to thereby secure the valve cap to the bone penetrating member. The valve cover includes a valve having an opening that has an open state in which the channel is not obstructed and a closed state that prevents the flow of material through the channel. The valve can repeatedly switch between open and closed states. The valve controls or regulates access to the canal by bone marrow sampling and biopsy instruments.

An advantage of the bone marrow access apparatus is that the valve cap serves two important functions, namely, it includes a valve that controls access to the channel and also includes a structure to allow it to be attached to the bone penetrating member. This structure may be one or more walls that define the interior cavity in which part of the bone penetrating member is located. By combining the fixation structure that fixes the valve cap and the bone penetrating member together with the valve, an improved bone marrow access apparatus is provided.

Another advantage of the bone marrow access apparatus is that it provides a cushioning effect by interposing an elastomeric material between the usually hard bone penetrating member and the bone surface. To this end, the valve cap includes a peripheral wall located outboard of the portion of the bone penetrating member, and a lower flange coupled to a lower edge region of the peripheral wall and which is made of a soft elastomer material or cushioning. The lower flange extends inwardly from the peripheral wall to cause the lower flange to lie between part of the bone penetrating member and a surface of the bone when the bone marrow access apparatus engages the bone. Therefore, the lower flange performs the cushioning effect and also serves to fix the valve cap to the bone penetrating member.

The valve cap may be provided on a proximal end portion of the bone penetrating member, in which case, the valve is located above the bone penetrating member, for example, on a top wall extending from an edge region top of the peripheral wall. At least this portion of the valve cap is preferably made of a soft elastomer that is atraumatic, although the entire valve cap may be made of an atraumatic material. The soft atraumatic cover is important to prevent erosion of the skin and tissues over the device. As an alternative position for the valve, it may be embedded (or recessed) in the channel of the bone penetrating member, whether the valve cap is at the proximal end portion of the bone penetrating member or elsewhere.

A bone marrow access system includes the bone marrow access apparatus as described above in any of its configurations and one or more instruments configured to pass through the opening at the proximal end of the channel into the interior of the channel and through of the opening at the distal end of the canal and, therefore, access the bone marrow space. These instruments can be straight sampling needles or sampling needles with a curved tip that can be driven to a straight condition to pass through the channel of the bone penetration member and otherwise will have its curved shape. The curvature of the tip allows greater penetration into areas of the marrow space for sampling and biopsy purposes.

Another object of one or more embodiments of the present disclosure is to provide a bone marrow access system that includes a bone marrow access apparatus as described above, tools for its installation and removal, and instruments with which it is used.

A bone marrow access system according to the disclosure includes a bone marrow access apparatus adapted to be installed in connection with a bone. The bone marrow access apparatus includes a bone penetrating member having a seat and an internal channel having an opening at a proximal end and an opening at a distal end, and a valve cap around at least part of the bone marrow access member. bone penetration. The valve cover includes a valve having an opening that has an open state in which the channel is not obstructed and a closed state that prevents the flow of material through the channel. Normally, the valve can repeatedly switch between open and closed states. The valve controls or regulates access to the canal by bone marrow sampling and biopsy instruments.

The system also includes a placement tool to install the bone marrow access apparatus in connection with the bone. The setting tool includes a handle, an elongated, preferably rigid shaft, attached at an end region to the handle, a flange attached to the shaft at an opposite end region of the shaft, and a drill bit extending outwardly from the shaft along below the flange and attached to the flange and/or to the tree. The flange is shaped to fit into the seat on the bone penetration member and configured with respect to the seat so that when the handle is rotated while the flange is in the seat, the bone penetration member is rotated. As such, when the bone marrow access apparatus is installed using the placement tool, the channel leads to the marrow space in the bone and is accessible to instruments through the valve and channel.

The drill bit preferably has a length greater than the length of the channel under the seat such that, when the flange is positioned on the seat, the drill bit extends beneath a bottom surface of the bone penetrating member. The seat and flange can have corresponding polygonal shapes.

The system may also include one or more instruments for accessing the marrow space while the bone marrow access apparatus is installed. Each instrument is sized to pass through the valve and canal openings to access the marrow space. Examples of instruments include straight sampling needles and curved sampling needles, the latter including a curved tip at a distal end which may assume a straight condition as it passes through the canal and may be provided with cutouts to improve its flexibility. The curvature of the tip allows greater penetration into areas of the marrow space for sampling and biopsy purposes. The channel and the instruments may have dimensions that depend on each other such that the instruments may tilt while in the channel. For example, when the instrument has a size of 13 G, the channel may be provided with dimensions (e.g., width and height) to allow this instrument to be tilted while in the channel by approximately 15 degrees all around. Similarly, when the instrument is 15 G in size, the canal may be provided with dimensions to allow this instrument to be tilted while in the canal by approximately 10 degrees all around.

In addition to or instead of the instruments, the system may include a removal tool for removing the bone marrow access apparatus from the connection to the bone. The removal tool includes a handle, an elongated shaft attached at an end region to the handle, and a flange attached to the shaft at an opposite end region of the shaft. The flange is similarly shaped to fit the seat, as the locating tool flange, and configured with respect to the seat so that when the handle of the removal tool is rotated while the flange of the removal tool is in the seat, the bone penetration member is rotated. Therefore, the removal tool flange, the placement tool flange and the seat can all have the same shape.

Brief description of the drawings

The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:

Figure 1 is a perspective view of a bone marrow access apparatus according to the invention;

Figure 2 is a front view of the bone marrow access apparatus shown in Figure 1;

Figure 3 is a cross-sectional view taken along line 3-3 in Figure 2;

Figure 4 is a rear perspective view of the valve cover of the bone marrow access apparatus shown in Figure 1;

Figure 5 is a rear view of the valve cover shown in Figure 4;

Figure 6 is a cross-sectional view taken along line 6-6 in Figure 5;

Figure 7 is a cross-sectional view showing the bone marrow access apparatus installed in connection with a bone;

Figure 8 is a view showing a preparatory stage for the installation of the bone marrow access apparatus shown in Figure 1;

Figure 9 is a perspective view of a placement tool used to install the bone marrow access apparatus shown in Figure 1;

Figure 10 is a view showing an initial installation step of the bone marrow access apparatus shown in Figure 1 with the placement tool shown in Figure 9;

Figure 11 is a view showing the final stage of installation of the bone marrow access apparatus shown in Figure 1 with the placement tool shown in Figure 9;

Figure 12 is a perspective view of a straight sampling needle used with the bone marrow access apparatus shown in Figure 1;

Figure 13 is a cross-sectional view of the sampling needle shown in Figure 12 shown in use; Figure 14 is a perspective view of a sampling needle with a curved tip used with the bone marrow access apparatus shown in Figure 1;

Figure 15 is a cross-sectional view of the sampling needle with a curved tip shown in Figure 14 shown during use;

Figure 16 is a perspective view of a removal tool used to remove the bone marrow access apparatus shown in Figure 1 from its installation in a bone; and

Figure 17 is a view showing the manner in which the bone marrow access apparatus shown in Figure 1 can be removed using a removal tool.

Detailed description

With reference to the accompanying drawings, in which like reference numerals refer to the same or similar members, Figures 1-3 show a bone marrow access apparatus 10 according to the invention. The bone marrow access apparatus 10 includes a bone penetration member 12 configured to penetrate a bone through the bone cortex to allow access to a marrow space in the bone during use of the bone marrow access apparatus 10. , and a valve cover 14 configured to control access to the marrow space through the bone penetration member 12 and partially cover the bone penetration member 12. The bone penetrating member 12 and the valve cap 14 are formed as independent components and are securely engaged together for use of the bone marrow access apparatus 10.

The bone penetrating member 12 includes an axially extending, substantially tubular insertion portion 16 having a spiral thread 18 on an outer surface 20 (see Figure 2). The spiral thread 18 allows the bone penetrating member 12 to be driven into the bone cortex upon rotation of the bone penetrating member 12 by a tool described below. An outer surface of the insertion portion 16 may be provided with grooved edges 22 on the underside thereof to assist in cutting into the bone cortex during installation of the bone marrow access apparatus 10.

The spiral thread 18 assists in the placement of the insertion portion 16 into the bone cortex, for example, allows the insertion portion 16 to be tapped or threaded into the bone cortex, and provides secure retention of the insertion portion 16. in the bone cortex and, therefore, the bone marrow apparatus 10 in its position of use in connection with the bone. Instead of a spiral thread 18, an alternative structure may be provided on the outer surface 20 of the insertion portion 16 that functions to allow insertion of the bone penetrating member 12 into the bone cortex and retention therein. Such an alternative structure is known to those skilled in the art to which this invention belongs, and any such structure that allows the insertion portion 16 to engage with and be retained in a bone is called an insertion and retention means in the bone. present document. Details of how the bone marrow access apparatus 10 is installed and used are described below.

The bone penetrating member 12 also includes a head portion 24 having a larger cross-sectional shape than that of the insertion portion 16. The head portion 24 has a bottom surface 26 adjacent to the insertion portion 16 and a step 28 peripherally outward from the bottom surface 26. The shoulder 28 provides an outer peripheral surface of the head portion 24 with a peripheral groove that engages with part of the valve cap 14 to provide secure engagement of the valve cap 14 to the bone penetration member 12 as discussed below. continuation. The head portion 24 may have a hexagonal cross section or a circular cross section in a plane perpendicular to the axial direction of the bone penetrating member 12, or may have other cross section shapes such as square, triangular, Torx type and the like. .

An internal channel 30 extends through the bone penetrating member 12 between an opening 32 at a proximal end 34 on the upper surface of the head portion 24, and an opening 36 at a distal end 38 at the bottom of the portion 24. 16 insertion. Through the channel 30, bone marrow can be extracted from the marrow space in the bone when the bone marrow access apparatus 10 is engaged with the bone. Removing bone marrow from the marrow space is commonly called bone marrow sampling.

To this end, the axial length of the insertion portion 16 of the bone penetration member 12 is sized to at least reach the marrow space of a particular bone when the head portion 24 is on the surface of the bone (see Figure 11). . Therefore, there may be a plurality of different lengths of insertion portions 16 of bone penetrating members 12, and a suitable length is selected based on the bone where the bone penetrating member 12 is being installed and possibly also on the size of the patient.

Part of the internal channel 30 is formed as a seat 40 below the upper surface of the head portion 24 (see Figure 3). The seat 40 is designed to act in conjunction with various tools to allow the bone penetrating member 12 to thread into the bone and to facilitate removal of the bone marrow access apparatus 10 therefrom (discussed below). The seat 40 may have a particular shape or construction to allow rotation of the tools to impart rotation of the bone penetrating member 12 when the tools are engaged with the seat 40 of the bone penetrating member 12. For example, a polygonal shape, e.g. hexagonal, is possible for the seat 40 with a corresponding hexagonal shape for a tool flange.

Another part of the channel 30 is formed as a valve release space 42 (see Figure 3). Valve release space 42 is designed to accommodate valve leaflets 52 that are pushed into channel 30 during installation and use of bone marrow access apparatus 10 (see Figures 8-10).

The internal channel 30 has a particular size to allow sampling of bone marrow when the bone marrow access apparatus 10 is in use. Channel 30 may have a diameter ranging from about 2.0 mm to about 4.2 mm (8-15 G) to allow the insertion of large needles and other types of conventionally used sampling instruments. The dimensions of the channel 30, that is, its length and diameter, are also selected to allow tilting of a sampling needle to allow it to reach new areas of the marrow space after repeated sampling. Therefore, the degree of inclination of the needle depends on the diameter of the needle and the diameter of the channel 30. In one embodiment, the channel 30 is sized to allow a needle having a size of 13G to tilt while in the channel. approximately 15 degrees in all directions with respect to a central axis of the channel 30, thereby providing a total degree of inclination of approximately 30 degrees. In another embodiment, channel 30 is sized to allow a needle having a size of 15 G to tilt approximately 10 degrees to each side, thereby providing a total degree of tilt of approximately 20 degrees. The 15 G needle can be used to sample cells via needle aspiration, while the 13 G instrument retrieves vermiform tissue samples and benefits more from tilting to extract from a fresh sampling zone. Of course, different combinations of needles and channels 30 of different sizes provide different inclination angles. A medical professional using the bone marrow access apparatus 10 can inquire about the needle sizes that can be used with each size of the bone marrow access apparatus 10 and the angles of inclination that can be obtained.

In a preferred embodiment, the bone penetrating member 12 is made of a rigid biocompatible material. Suitable materials include, but are not limited to, stainless steel, titanium, nitinol and polyether ether ketone (PEEK).

Various constructions of bone penetrating member 12 and valve cap 14 are provided to provide secure retention of valve cap 14 in connection with bone penetrating member 12 for installation and use of bone marrow access apparatus 10. . One such construction is to provide the valve cover 14 with one or more walls that define an interior cavity 44 sized to accommodate at least part of the bone penetrating member 12.

In the illustrated embodiment, the valve cap 14 includes a peripheral wall 46 disposed outwardly from the head portion 24 of the bone penetrating member 12 (see Figures 4 and 6). The peripheral wall 46 may completely surround the head portion 24 of the bone penetrating member 12 with which the valve cap 14 is operatively coupled. The peripheral wall 46 has an interior surface that has generally the same shape in cross section (in a plane perpendicular to the axis of the bone marrow access apparatus 10) as the external surface of the head portion 24 of the bone penetrating member 12, and which is only slightly larger to provide a tight fit between the valve cap 14 and the bone penetrating member 12.

The valve cover 14 also includes an upper wall 48 extending inwardly from an upper edge region of the peripheral wall 46 and a lower rim 50 extending inwardly from a lower edge region of the peripheral wall 46 (see figure 6). When the valve cap 14 is engaged with the bone penetrating member 12, the upper wall 48 is located above the upper surface of the head portion 24 of the bone penetrating member 12 and the lower rim 50 is on the step 28 and, therefore, is below a peripheral edge region of the head portion 24 of the bone penetrating member 12 (see Figure 3). With the upper wall 48 above the head portion 24 and the lower rim 50 at the step 28 below the head portion 24, the valve cap 14 is secured to the bone penetrating member 12.

In place of the peripheral wall 48 and the lower rim 50, another structure can be used in the invention to secure the valve cap 14 to the bone penetrating member 12, either the head portion 24 or another part of the bone penetrating member 12. . Such an alternative fixing structure that performs the same function as the peripheral wall 48 and the lower rim 50 in the same or a similar manner can be easily determined by those skilled in the art to which this invention belongs and is considered to be within of the scope of the invention. All such structures are considered to be included within the term fixation means for securing the valve cap to the bone penetrating member.

An important feature of the valve cap 14 is that at least the portion above the head portion 12 of the bone penetrating member 12 is made of atraumatic material, that is, part or all of the upper wall 48. Soft elastomers which are known to be atraumatic are preferably used. The use of atraumatic material prevents damage to the skin above the bone marrow access apparatus 10 when present in a human body. It is possible to form the valve cover 14 entirely of atraumatic material. Exemplary characteristics of an atraumatic material include that it is soft and has a low durometer hardness, the purpose being to prevent erosion and degradation of the skin and to provide a cushioning layer between the skin and the bone penetrating member.

The upper wall 48 includes a valve 52 located completely above the bone penetration member 12 and having an opening 54 that controls access to the channel 30 (see Figures 1 and 6). It is contemplated that the valve 52 may be located in a portion of the valve cap 14 other than the top wall 48. For example, the valve 52 may be embedded (or recessed) in the channel 30 of the bone penetrating member 12.

The valve opening 54 has an open state in which the channel 30 is not obstructed and a default closed state in which it is closed and the flow of material between the openings 32, 36 of the channel 30 is prevented. In one embodiment, The valve cover 14 only includes a single valve.

The valve 52 has a particular construction to allow the valve opening 54 to repeatedly switch between the open and closed states. For example, valve 52 may be a single slot valve as shown in Figure 1, or alternatively, an intersection slot valve. Such valves have leaflets 56 that come into contact with each other in a default closed state and must be pushed away from each other to form the opening 54. When pushed away from each other, for example, by introducing a sampling needle through From the channel 30 into the marrow space in the bone, the leaflets 56 are housed in the valve release space 42. Valve 52 may also be a duckbill valve. Generally, the valve 52 is designed for repeated opening and closing of the opening 54, without losing integrity or detaching fragments thereof.

Valve 52 is representative of an access control component that controls access to channel 30 and other access control components that perform the same functions for valve 52 described herein may be used as an alternative to valve 52. Such Alternative access control structure that performs the same function as the valve 52 in the same or a similar manner can be readily determined by those skilled in the art to which this invention belongs and is considered to be within the scope of the invention . A valve and all comparable access control components of this type are considered to constitute access control means for controlling access to channel 30.

In one embodiment, the valve cover 14 has a unitary construction. This means that it is formed as a single unit or a single piece. It may be made entirely of substantially the same soft elastomer, preferably one that has a durometer hardness of 5-50 Shore A. For example, the valve cap 14 may be made of silicone or polyurethane.

The bone marrow access apparatus 10 is installed in connection with a bone 8 since only part of the bone marrow access apparatus 10 is located in the bone 8 (for example, the insertion portion 16 of the bone penetrating member 12 as shown in Figure 7) while another part is located on, above and/or outside the bone 8 (for example, the head portion 24 of the bone penetrating member 12 and the valve cap 14 as shown in Figure 7).

A typical, but not limiting, installation of the bone marrow access apparatus 10 in connection with a bone involves first connecting the bone penetrating member 12 and the valve cap 14. This is accomplished by inserting the head portion 24 of the bone penetrating member 12 through an opening 56 defined by the lower flange 50 into the interior cavity 44 until the lower flange 50 has been driven toward the step 28 in the portion 24 head of member 12 bone penetration. The head portion 24 should fit tightly into the interior cavity 44 defined by the valve cover 14.

For the insertion of the insertion portion 16 of the bone penetration member 12 into the bone 8, a placement tool 70 is specially designed for this purpose, shown in Figures 8 and 9. The placement tool 70 includes a handle 72 and a rigid and elongated shaft 74 attached at an end-to-handle region 72 and attached at an end region opposite a flange 76. A drill bit 78 is attached to the shaft 74 below the flange 76 or may be attached to the flange 76 The flange 76 is shaped to fit into the seat 40 in the head portion 24 of the bone penetrating member 12 (see Figures 10 and 11).

The dimensions of the placement tool 70 are specific to the particular bone penetration member 12 being installed, so that a plurality of placement tools 70 may be required for a differently sized bone penetration member 12. More particularly, the length of the drill bit 78 should be greater than the length of the channel 30 in the insertion portion 16 so that, when the flange 76 is located in the seat 40, the drill bit 78 will extend below the surface 20 bottom of the insertion portion 16 of the bone penetration member 12 (see Figure 11). This is necessary because the drill bit 78 often creates or completes the drilling of a bone channel through the bone cortex to the marrow space 2, which bone channel begins with a preliminary hole 4. Obviously, the diameter of the drill bit 78 must be smaller than the diameter of the channel 30 to allow the drill bit 78 to enter and pass through the channel 30 (see Figures 10 and 11).

In an exemplary installation method using the tool 70, the handle 72 of the placement tool 70 is grasped and the drill bit 78 is aligned with the opening in the valve 52 leading to the channel 30 while the apparatus 10 of bone marrow access has not yet been inserted into bone 8 (figure 8). Drill bit 78 is then inserted through opening 54 in valve 52 into channel 30 until flange 76 rests on seat 40 (Figure 10).

The tool 70, with the bone marrow access apparatus 10 attached, is inserted through an incision in the patient's skin to insert the insertion portion 26 of the bone penetrating member 12 into the preliminary hole 4. Therefore, the bone marrow access apparatus 10 is inserted into the preliminary hole 4 in the bone 8 which extends from the outer surface 6 of the bone 8 towards the marrow space 2, which preliminary hole 4 can be formed only initially by the drill bit 78 (see figure 10). This insertion is aided by the thread 18 on the outer surface 20 of the insertion portion 16 of the bone penetrating member 12 which grips the surface of the bone cortex defining the preliminary hole 4. In one embodiment, the preliminary hole 4 may be formed by piercing the bone 8 using a bone puncture needle. For example, preliminary hole 4 may be created through the cortical layer. Alternatively, the self-tapping placement tool 70 may create the preliminary hole 4 as it positions the bone marrow access apparatus 10.

The tool 70 is then rotated, while holding the flange 76 in the seat 40, to cause the bone penetrating element 12 to be further inserted into the bone 8. Rotation of the tool 70 continues until the drill bit 78 completes one channel through the bone cortex into the marrow space 2 and the lower surface of the lower rim 50 of the valve cover 14 rests on the surface 6 of the bone 8 (Figure 11).

By interposing the lower rim 50 between the head portion 24 of the bone penetrating member 12 and the surface 6 of the bone 8, the lower rim 50 provides a cushioning effect. The lower flange 50 is preferably made of a soft elastomer that can be compressed and therefore cushions the impact of the head portion 24 of the bone penetrating member 12 against the bone surface 6.

After the bone marrow access opening 10 reaches the position shown in Figure 11, the tool 70 is removed from the engagement with the bone marrow access apparatus 10 by lifting it upward. The tool 70 is then withdrawn through the opening 54 defined by the valve 52 causing the opening 54 in the valve 52 to close. The tissues above the apparatus are then surgically closed. The final installed position of the bone marrow access apparatus 10 is shown in Figure 7. Note that no glue or other adhesive is required to install the bone marrow access apparatus 10.

Once the bone marrow access apparatus 10 is installed in connection with a bone 8, it can be used to sample bone marrow whenever such sampling is desired for either biopsy or aspiration depending on which instrument is used. Each time bone marrow is sampled, the surgeon will press the skin in the known area of the bone marrow access device 10 to locate the bone marrow access device 10. Once located, the surgeon will press the skin over the valve cap 14 and insert an instrument such as a sampling needle through the skin and through the opening 54 of the valve 52 into the channel 30 and out of the opening. 38 distal of channel 30 into the marrow space 2. Obviously, a sampling needle or other type of instrument is selected that has a size (gauge) that fits in channel 30. The depth of penetration of the sampling needle or other instrument into marrow space 2 can also be varied. by the surgeon.

If a straight sampling needle 66 is selected, the sampling needle 66 can be tilted to sample a new area of the marrow space 2 to extract bone marrow (see Figures 12 and 13).

Alternatively, a curved sampling needle 80 may be used (Figure 14). The curved sampling needle 80 includes an inner tube 82 with a bend at a distal end and a straight outer tube 84. The curved inner tube 82 allows bone marrow to be sampled from a larger region of the marrow space 2, as it can be inserted to different depths and rotated to reach different directions (see Figure 15). To assist in bending the inner tube 82, it is optionally provided with cutouts 98 in the distal end region. These cutouts 98 can be formed by a laser.

The curved sampling needle 80 may be made of nitinol and the curved inner tube 82 sharpened to facilitate marrow penetration. The curved inner tube 82 adopts a straight condition as it passes through the channel 30, as it is retained in the straight outer tube 84, but then curves to its initial condition after passing through the opening 36 and then out. of the outer tube 84 (figure 14). The inner tube 82 is made of a material that is rigid enough to push through the outer tube 84 to collect a tissue sample, but is configured to return to a curved state at the distal end to increase the sampling area, and such materials are known or can be readily determined by those skilled in the art to which this invention belongs in view of the description herein. Instead of a straight outer tube 84, a straight inner stylet may be provided to allow the curved inner tube 82 to enter and pass through the channel 30, and then unsheath the inner tube 82 to allow it to return to its curve. natural when the marrow space for sampling is reached.

In one embodiment, the needles 66, 80 have a stylet that allows the needles 66, 80 to penetrate the skin and reach the location in the marrow space of the bone. The stylet is removed allowing the hollow channel to now aspirate or biopsy the marrow. Without using the stylet, the needles 66, 80 would scrape the skin and muscles as they are pushed. It is also possible to use a guided needle which, with a stylet, will be pushed into the marrow space and then, when the stylet is removed, different needles can be inserted through the canal to sample marrow without having to penetrate new skin with each needle.

Regardless of what type of sampling needle is used, after sampling is completed, the needle is removed from channel 30 and drawn through valve 52 and the skin. The valve 52 closes its opening 54, thus preventing material from flowing out and into the marrow space 2.

The sampling needles 66, 80 preferably include insertion depth indicators so that the surgeon can read the indicators and determine the sampling depth. This allows the surgeon to sample different depths in bone marrow space 2 at different times, for example, to sample in week 1 at depth X and in week 2 at a different depth Y.

Once the bone marrow access apparatus 10 is no longer necessary for bone marrow sampling, it can be removed. Removal generally involves rotating the bone marrow access apparatus 10 out of the hole in the bone 8. If provided with a spiral thread 18, this can be accomplished by grasping the valve cap 14, applying pressure against the head portion 24. of the bone penetration member 12 and then rotating it in the opposite direction to the direction in which the bone penetration member 12 was inserted into the bone hole 8.

A removal tool 86 is specially designed to facilitate the removal of the bone marrow access apparatus 10 (Figure 16). The removal tool 86 includes a handle 88 and a shaft 90 attached in an end region to the handle 88 and attached in an opposite end region to a flange 92. The flange 92 is shaped to fit into the seat 40 in the portion 24. head of bone penetration element 12.

For removal of the bone marrow access apparatus 10, the surgeon inserts the removal tool 86 through an opening in the skin over the bone marrow access apparatus 10 and then inserts the removal tool 86 through the opening. 54 in the valve 52 into the channel 30 until the flange 92 rests on the seat 40 (figure 17). The tool 86 is then rotated, while holding the flange 92 in the seat 40, to cause the bone penetration member 12 to be withdrawn from the bone hole. Rotation of the tool 86 continues until the insertion portion 16 of the bone penetrating member 12 is completely free of the bone and then the tool 86 and the bone marrow access apparatus 10 engaged therewith are extracted through the skin. of the patient. The valve cap 14 holds the bone penetrating member 12 on the removal tool 80 as it is lifted. The leaflets 56 will be on the top of the flange of the removal tool 80 with some counterforce.

The insertion and removal tools 70, 86 may be single-use tools or designed for multiple uses.

Variations of the embodiments described above and illustrated in the drawings are considered to be within the scope of the invention and, therefore, the scope of the invention should be determined by the appended claims, rather than by the examples provided.

Claims (13)

Yo. A bone marrow access device (10) comprising: a bone penetrating member (12) having an internal channel (30) having an opening (32) at a proximal end (34) and an opening (36) at a distal end (38); and a valve cover (14) engaged with the bone penetration member (12), the valve cover (14) defining an interior cavity (44) in which at least part of the bone penetration member (12) is located, wherein the valve cover (12) comprises a valve (52) having an opening (54) that has an open state where the channel (30) is not obstructed and a closed state that prevents the flow of material through said channel, wherein the valve (52) can repeatedly switch between the open and closed states, wherein the valve cover (14) comprises a peripheral wall (46), an upper wall (48) provided above the penetration element (12) bone and extending inwardly from an upper edge region of the peripheral wall (46), characterized in that the valve cap (14) further comprises a lower edge (50) extending inwardly from a lower edge region of the peripheral wall (46), and the valve (52) is provided in the upper wall (48), wherein the bone penetration member (12) has a top surface and a seat (40) that is below the top surface , and the seat can be coupled with an installation or removal instrument (70, 86) to install or remove the bone penetration member (12) in the bone (8), and where the seat (40) is part of the internal channel (30). 2. The bone marrow access apparatus (10) of claim 1, wherein: The bone penetrating member (12) comprises an axially extending insertion portion (16) and a head portion (24) having a larger cross-sectional area than the insertion portion (16); and the channel (30) extends through the insertion portion (16) and the head portion (24) between the openings (32, 36) at the proximal and distal ends (34, 38); 3. The bone marrow access apparatus of claim 1 or 2, wherein the bone penetration member (12) comprises: a thread (18) on an outer surface thereof; and grooved edges (22) at a distal end thereof; wherein the fluted edges are provided in a plurality of positions around the opening (36) at the distal end (38) of the channel (30). 4. The apparatus of any one of claims 1 to 3, wherein the seat (40) has a polygonal shape. 5. A bone marrow access system that includes: the bone marrow access apparatus (10) according to any one of claims 1 to 4; and an installation instrument (70) comprising: a flange (76); and a drill bit (78) that extends beyond the flange (76), wherein the flange (76) is shaped to fit into the seat (40) of the bone marrow access device (10). 6. The bone marrow access system of claim 5, wherein: The bone penetrating member (12) comprises an axially extending insertion portion (16) and a head portion (24) having a larger cross-sectional area than the insertion portion (16); and the channel (30) extends through the insertion portion (16) and the head portion (24) between the openings (32, 36) at the proximal and distal ends (34, 38); 7. The bone marrow access system of claim 5 or 6, wherein the bone penetration member (12) comprises: a thread (18) on an outer surface thereof; and grooved edges (22) at a distal end thereof; wherein the fluted edges are provided in a plurality of positions around the opening (36) at the distal end (38) of the channel (30). 8. The bone marrow access system of any one of claims 5 to 7, wherein the seat (40) has a polygonal shape, and the flange (76) has a corresponding polygonal shape. 9. The bone marrow access system of any one of claims 5 to 8, wherein the seat (40) is positioned to be accessible by the installation instrument (70) by inserting the installation instrument (70) through the valve (52). 10. The bone marrow access system of any one of claims 5 to 9, wherein the installation instrument (70) further comprises a handle (72) and an elongated shaft (74) attached at one end to the handle (72). ) and at the other end to the flange (76), and the drill bit (78) is attached to the flange (76). 11. The bone marrow access system of any one of claims 5 to 10, wherein the drill bit (78) has a length greater than the length of the channel (30) under the seat (40) so that when the flange (76) is located in the seat (40), the drill bit (78) extends below a lower surface (20) of the bone penetration member (12). 12. The bone marrow access system of any one of claims 5 to 11, further comprising: at least one sampling needle (66, 80) that can be inserted through the valve (52). 13. The system of any one of claims 5 to 12, further comprising: a removal tool (86), wherein the removal tool comprises: a flange (92) at one end shaped to fit the seat (40); a handle (88); and an elongated shaft (90) joined at an end region to the handle (88), the flange (92) is joined to the shaft (90) at an end region opposite the shaft of the handle (88).